A federal appeals court on Monday declined to revive hundreds of lawsuits by women who claim that GlaxoSmithKline Plc failed to warn them that taking the anti-nausea drug Zofran during pregnancy could cause birth defects.
that federal law preempts the plaintiffs' state-law claims that GSK failed to warn doctors and pregnant women that animal studies found a link between birth defects and taking Zofran.by U.S. District Judge F. Dennis Saylor that marked the end of 425 lawsuits consolidated before him in long-running multidistrict litigation.
The plaintiffs' lawyers contended that Japanese animal studies they claimed GSK had withheld from the FDA would have justified a change on the drug's warning label indicating the studies revealed adverse effects on the fetus. Without any newly acquired information, GSK could not legally change the label without the FDA's blessing, Kayatta wrote.
The 2021 update was in response to a request by Novartis AG, which was not a party to the litigation but had acquired Zofran from GSK in 2015 and proposed warning of the risks of harm to fetuses.
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